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Question about AEs and SAEs

Hi,

I'm still learning about the clinical trial industry... this question has two parts,
a) on the business and operation's side, my guess is, when an AE happens and particularly SAE the PI needs to be notified asap, does finding, recording and reporting such event a site CRC's job?  And what's CRA's role in AEs and SAEs if any?
b) I ran a quick test by adding an AE event. 
Naturally the following sql query found it,
   select se.*
   from study_event se, study_event_definition sed
   where se.study_event_definition_id = sed.study_event_definition_id
and sed.name = 'Adverse Events'
question, when or if such an AE or SAE event goes to the event_crf table?  If so how does it happen (who and what actions has/have happened, detailed work flow for this)?

Many thanks.

Don


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Comments

  • kristiakkristiak Posts: 1,334 ✭✭✭

    Hi Don,

    a) This rally depends on how the responsibilities are distributed within the specific study. Normally the CRC enters all data. If an AE or serious AE is reported it is up to the PI to evaluate it on the AE page. For SAE's a much more detailed form needs to be completed very quickly depending on in which country study is being performed. This will the responsibility of the  CRA or project manager to make sure this form is submitted to the authorities within the timeframes required by local law.

    b) To make sure that the correct people are notified whenever a serious AE is entered into OpenClinica you create a rule as outlined below! This rule will notify anyone specified if a serious AE is entered into the system. You never have to resort SQL queries. This run fully automatic!

    <!--
    Rules for CRF AE
    Cretated by Krister Kristianson
    http://www.e-source.se
    Last updated: 2012-05-22

    Variables:
    Study Event OID :SE_IUD
    CRF version OID :F_IUDINSERTION
    Group OID  :IG_AE_AE    repeating group for AE's
    Item OID  :I_AE_AE4   AE yes=1; no=0

    -->
    <RuleImport>
    <!-- Serious AE MAIL -->
     <RuleAssignment>
      <Target Context="OC_RULES_V1">SE_AE.F_AE.IG_AE_AE.I_AE_AE4</Target>
      <RuleRef OID="R_F_AE_SER_1">
       <EmailAction IfExpressionEvaluates="true">
        <Message>A Serious AE has been reported that needs your attention</Message>
        <To>[email protected],[email protected],[email protected]</To>
       </EmailAction>
      </RuleRef>
     </RuleAssignment>
    <!-- *****-->
    <!-- Serious AE mail -->
     <RuleDef OID="R_F_AE_SER_1" Name="Send mail when AE is serious">
      <Description>Send mail if AE evaluates to SERIOUS</Description>
      <Expression>I_AE_AE4 eq 1</Expression>
      </RuleDef>
     
     
    </RuleImport>


  • cra360cra360 Posts: 56
    Krister,

    Thank you for your insight into AEs and SAEs.  The challenge at my hand is to figure out how the CRA or CRAs handle AEs and SAEs at a site because my goal is to evaluate the CRA or CRAs performance at a particular site, thought this element may provide a relevant data point for my task.

    And I need to explore more than OC... tough challenges...

    Cheers,

    Don


  • vidyadharpujarividyadharpujari Posts: 11
    Hi Don,

    To evaluate performance of the CRAs you can check how many AEs and SAEs reported at the site and out of the how many were reported to the regulatory authorities in time.

    Hope this helps.

    Regards

    Dr. Vidyadhar S Pujari
  • cra360cra360 Posts: 56
    Dr. Pujari,

    Thank you for your thought on AEs and SAEs.  Now, let's say EDC such as OC contains AEs and SAEs hence, I can track who handles them and possibly how they handle them.  As for tracking if they "were reported to the regulatory authorities in time", say, FDA for US trials, how would we be able to check such info?  Would clinicaltrials.gov a starting point?  And if so, trial/study record that they provide does not seem to contain AEs and SAEs.

    Best,

    Don
  • kristiakkristiak Posts: 1,334 ✭✭✭

    Hi Don,

    This depends on you role in the study. Assuming that you are in charge of the project at the sponsor, then it is your responsibility to report AE's and SAE's to the agencies. You will most likely want to create an AE database and from this monitor that they are reported as per your SOP's. This would be your a actions if you were to Medical Director or Research Director at the sponsor.

    Regards


    Krister


  • cra360cra360 Posts: 56
    Krister,

    Thanks for your insight.

    Cheers,

    Don
This discussion has been closed.